QA Specialist - GMP / Medical Devices

Job Title: Quality Assurance Specialist – GMP / Medical Devices

Job Location: Foster City, California

Job Duration: 12 months

Onsite Position: Foster City - 5 days/week - Local Candidates

The Device Engineering team is seeking a qualified individua l to support drug device combination products throughout the commercial lifecycle.

This individual will be responsible for the management of combination product change records. Additional responsibilities include post market surveillance reports, risk management file maintenance, and general project management across the combination product portfolio.

Job Responsibilities

· Coordinate and manage combination product change control records –

o Initiate, route, and close change records for product and manufacturing process changes.

o Initiate, route, and close change records for the design and development of drug device combination products, including the creation and management of design control documentation.

o Manage implementation of changes at multiple manufacturing sites and change record closures.

· Coordinate post-market surveillance reports and risk management file updates –

o Collate surveillance information into yearly reports.

o Generate annual risk summaries and update risk management files.

· Support complaint investigations and documentation.

· Act as a central hub between cross-functional teams to ensure supply continuity.

Knowledge & Skills

· Exceptional organizational and time management skills .

· Understanding of c hange controls in a regulated industry.

· Experience with project management.

· Working knowledge of r elevant US, EU, and international medical device and pharmaceutical regulations.

· Experience with Veeva Vault.

· Ability to work with team members, vendors, suppliers, and contract manufacturers to coordinate changes.

Education & Experience

· 3 – 5 years relevant experience in related field and a BS or BA.

· Experience with medical device development and / or pharmaceutical operations (cGMP environment) required.